Wang Juan, Du Ling-yao, Zhu Xia, Chen En-qiang, Tang Hong
Center of Infectious Diseases,West China Hospital of Sichuan University; Division of Infectious Diseases, State Key Laboratory of Biotherapy, Sichuan University, Chengdu, Sichuan, China.
Indian J Med Microbiol. 2015 Feb;33 Suppl:20-5. doi: 10.4103/0255-0857.148827.
Through an observation on HBeAg-positive chronic hepatits B (CHB) patients in Telbivudine (LDT) treatment for 104 weeks, we tried to explore valuable early predictors for HBeAg seroconversion during the treatment.
A prospective study lasting for 104 weeks was conducted, and the patients enrolled were administered with LDT 600 mg daily. The medical evaluation went every 12 weeks, then the age distribution, baseline ALT level, early HBVDNA, HBsAg and HBeAg levels at baseline, week 12 and 24 as well as the decrease of the three indicators at week 12 and 24 were analyzed for their predictive values for HBeAg seroconversion at week 104.
Thirty-three patients finished the observation. All patients got ALT normalisation and 28 patients (84.84%) got complete virological response (HBV DNA<291 copies/ml) at week 104. Poor virological response and virologic breakthrough was observed in two (6.06%) and three patients (9.09%), respectively. Nine patients (27.27%) got HBeAg seroconversion. HBeAg levels and its decrease levels at week 12 and 24 showed significant differences between patients with and without HBeAg seroconversion. And the HBsAg levels at week 12 and 24 showed tendencies of significant differences in two groups. HBeAg level at week 24 was confirmed related to its longer term seroconversion in regression analysis. The patients with HBeAg level<2.1 S/CO at week 24 would be more possible to get HBeAg seroconversion at week 104, with sensitivity, specificity, positive and negative predictive value of 95.83%, 88.89%, 95.8% and 88.9%, respectively.
Good efficacy of long-term LDT treatment in biological and virological response and its advantage in serological response was confirmed again in our study. The HBeAg level at week 24 showed significant value in prediction for HBeAg seroconversion at week 104 compared to other serological markers in the early period.
通过对替比夫定(LDT)治疗104周的HBeAg阳性慢性乙型肝炎(CHB)患者进行观察,试图探索治疗期间HBeAg血清学转换的有价值的早期预测指标。
进行了一项为期104周的前瞻性研究,纳入的患者每日服用600mg LDT。每12周进行一次医学评估,然后分析年龄分布、基线ALT水平、早期HBVDNA、基线、第12周和第24周时的HBsAg和HBeAg水平以及第12周和第24周时这三项指标的下降情况对第104周时HBeAg血清学转换的预测价值。
33例患者完成观察。所有患者在第104周时ALT均恢复正常,28例患者(84.84%)获得完全病毒学应答(HBV DNA<291拷贝/ml)。分别有2例(6.06%)和3例患者(9.09%)观察到病毒学应答不佳和病毒学突破。9例患者(27.27%)发生HBeAg血清学转换。有和没有HBeAg血清学转换的患者在第12周和第24周时的HBeAg水平及其下降水平存在显著差异。并且两组在第12周和第24周时的HBsAg水平有显著差异的趋势。回归分析证实第24周时的HBeAg水平与其长期血清学转换有关。第24周时HBeAg水平<2.1 S/CO的患者在第104周时更有可能发生HBeAg血清学转换,其敏感性、特异性、阳性和阴性预测值分别为95.83%、88.89%、95.8%和88.9%。
我们的研究再次证实了长期LDT治疗在生物学和病毒学应答方面的良好疗效及其在血清学应答方面的优势。与早期的其他血清学标志物相比,第24周时的HBeAg水平对第104周时的HBeAg血清学转换具有显著的预测价值。